Effect of BFR Rehab After Achilles Tendon Rupture
ConditionAchilles Tendon Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Achilles Rupture confirmed by MRI or Thompson Test
Adult
Receiving Percutaneous Achilles Repair System (PARS) or open repair
Proposed PT with Methodist Location
Disqualifiers
Obesity (BMI>35)
Diabetes
Cardiovascular, renal, liver or pulmonary disease
Active infections
Trial design
Design model
Parallel
Treatments tested in this trial
Blood flow restriction with Delfi Personalized Tourniquet System (PTS)
DeviceStandard of care physical therapy exercises with the use of the Delfi PTS cuff
Physical therapy
Other interventionStandard of care physical therapy exercises
Treatment groups
19 Participants
are divided into 2 treatment groupsGroup A: Blood flow restriction groupExperimental treatment 2 interventions
Group B: Standard of Care (control) groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Muscle mass preservation
Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).
Time frame
pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op2
Bone density preservation
Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).
Time frame
pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op3
Improve patient reported outcomes (Physical activity)
Digital RedCap survey tool sends Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function survey which consists of questions about their physical health and patient responds with Excellent, Very Good, Good, Fair or poor. Using healthmeasures.net, responses are converted to T-scores based on the general population. The highest the T-scores, the better physical health the patient has.
Time frame
pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op4
Improve patient reported outcomes (Pain)
Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).
Time frame
pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-opSponsors and contacts
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Source ClinicalTrials.gov